Visual Perceptual Learning Based Digital Therapeutics for Stereopsis in Intermittent Exotropia

NCT06117813 | Completed

• 1 other identifier: NNS-IXTS-01
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 6

Brief Summary

This study evaluates the efficacy and safety of visual perceptual learning for improving stereopsis in intermittent exotropia. Half of participants will receive visual perceptual training using the Nu.T. The other half will not receive any training because there is no standard treatment for decreased stereopsis in intermittent exotropia.

Conditions

Intermittent Exotropia

Outcome Measures

Primary Outcomes (1)

• Changes in (log) arc second of stereopsis from Baseline to 8 weeks

  Stereopsis will be evaluated by a Titmus Dot Test.

  8 weeks

Secondary Outcomes (6)

• Proportion of subjects showing improved stereopsis at 8 weeks compared to baseline

  8 weeks

• Changes of Stereopsis based on Titmus Symbol Test from baseline to 8 weeks

  8 weeks

• Changes of Stereopsis based on Distance Randot Stereotest from baseline to 8 weeks

  8 weeks

• Changes of strabismus angle from baseline to 8 weeks

  8 weeks

• Changes of convergence capability score from baseline to 8 weeks

  8 weeks

Study Arms (2)

Nu.T

EXPERIMENTAL

Nu.T, 5 times a week for 8 weeks.

Device: Nu.T

No-treatment Control

OTHER

No-treatment was administered during control period.

Other: No-Treatment Control

Interventions

Nu.T DEVICE

Participants receive visual perceptual training using the Nu.T software.

Nu.T

No-Treatment Control OTHER

No-treatment was administered during control period.

No-treatment Control

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Intermittent Exotropia patients aged 6 to 15
• Patients with decreased stereopsis above 50 arc seconds in Titmus Dot Test
• Able to use the Virtual Reality(VR) device
• Patient or legally authorized representative has signed the informed consent form

You may not qualify if:

• Incomitant strabismus patient with impaired eye movement
• Patients with amblyopia (Maximal corrective vision of one eye is less than 0.8 or maximal corrective vision both eyes more than two lines of difference)
• History of ophthalmic surgery
• Patient who has undergone or is currently undergoing cover treatment within one month for the purpose of treating strabismus or amblyopia
• Scheduled for ophthalmic surgery during the clinical trial participation period (8 weeks in the treatment group as of the registration date, Maximum 16 weeks in the control group as of the registration date)
• Difficult to understand and perform the stereopsis test.
• Abnormal Retinal Correspondence
• Patient with neurological abnormalities other than strabismus
• History of premature birth
• Participating in other clinical trial
• Any other condition that, in the opinion of the investigator, precludes participation in the trial

Sponsors & Collaborators

• Nunaps Inc: lead

Study Sites (6)

Inje University Ilsan Paik Hospital

Goyang, South Korea

Location

Hangil Eye Hospital

Incheon, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Konkuk University Hospital

Seoul, South Korea

Location

Nowon Eulji Medical Center, Eulji University

Seoul, South Korea

Location

Uijeongbu Eulji Medical Center, Eulji University

Uijeongbu-si, South Korea

Location

Study Officials

• Yeji Moon, MD, PhD

  Asan Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 7, 2023
• Study Start: December 22, 2023
• Primary Completion: June 12, 2025
• Study Completion: July 16, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

KR (6)